Clomiphene Citrate for Treatment of Acromegaly Not Controlled by Conventional Therapies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- IGF-1 Levels
研究概览
简要总结
To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)
详细描述
Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. Despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients
Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes.
The aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment.
In this prospective, open label, single center trial, sixteen male patients were studied. Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. Hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with active acromegaly on regular use of a stable dose of Octreotide-LAR and/or cabergoline for at least one year,
- •Insulin like growth factor 1 above the reference range during the last year of follow-up and
- •testosterone levels within or below the third inferior tertile of normality.
排除标准
- •radiotherapy in the last 10 years, previous venous embolism (including family members),
- •previous prostatic cancer or symptomatic benign hypertrophy,
- •triglyceride levels above 400 mg/dL,
- •renal failure defined by estimative of renal filtration below 30 ml/min,
- •liver disease defined by hepatic enzymes 3 times above normal limit,
- •active oncologic disease in the last 10 years and previous cardiac or cerebrovascular disease.
研究组 & 干预措施
Clomiphene citrate
Patients receiving clomiphene citrate
干预措施: Clomiphene Citrate (Drug)
结局指标
主要结局
IGF-1 Levels
时间窗: Day 90
The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
次要结局
- Testosterone Levels(D90)
- PSA Levels(Day 90)
研究者
Felipe Henning Gaia Duarte
MD, PhD
University of Sao Paulo General Hospital